Recalls / —

—#207882

Product

Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502

FDA product code

BXN — Stimulator, Nerve, Battery-Powered

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K860126

Affected lot / code info

Catalogue Number: 4894502; UDI/DI: 04022495101310; Lot/Batch: 20E01, 20E03, 21E07, 21E09, 19E10, 22E10, 22E11, 21E13, 20E19, 20E20, 19E21, 19E22, 20E22, 23E26, 20E27, 23E31, 19F12, 19F13, 19F15, 19G03, 19G04, 19G06, 19G09, 19G20, 19G21, 19G24, 19G25, 19G27, 19H23, 19H28, 19H30, 19I11, 19I21, 19I25, 19I26, 19K11, 19K16, 19K17, 19K24, 19K25, 19L12, 19L13, 19L15, 19L19, 19M12, 19M14, 19M17, 19M21, 19M24, 19M26, 20A30, 20A31, 20B15, 20B18, 20B19, 20B21, 20B26, 20B27, 20C14, 20C17, 20C18, 20D01, 20D02, 20D04, 20D14, 20D16, 20D17, 20D21, 20D29, 20F06, 20F10, 20F11, 20F12, 20F13, 20G21, 20G22, 20G23, 20G29, 20G31, 20H01, 20H05, 20H26, 20H27, 20H29, 20L27, 20L28, 20M03, 20M19, 20M23, 20M25, 20M26, 21A16, 21A19, 21B04, 21B06, 21B10, 21B18, 21B20, 21B25, 21C11, 21C13, 21C17, 21D07, 21D08, 21D10, 21D29, 21F19, 21F23, 21F24, 21F25, 21F26, 21F30, 21G08, 21G09, 21G10, 21G14, 21G17, 21G20, 21G21, 21H05, 21H06, 21H07, 21H26, 21H28, 21I04, 21I22, 21I26, 21K07, 21K09, 21K13, 21K29, 21K30, 21L16, 21L17, 21L18, 21L19, 21L20, 21L30, 21M02, 21M03, 21M11, 21M14, 22A08, 22A25, 22B25, 22B27, 22C02, 22C03, 22C25, 22C29, 22D14, 22D15, 22D19, 22D21, 22F02, 22F04, 22G14, 22G16, 22G21, 22G23, 22G29, 22H25, 22I01, 22I03, 22I08, 22I28, 22K01, 22K05, 22K16, 22K18, 22K19, 22K20, 22L01, 22L02, 22L15, 22L16, 22M06, 22M15, 22M17, 23A08, 23A11, 23A31, 23B01, 23B07, 23B25, 23B28, 23C16, 23C18, 23C21, 23D19, 23D22, 23D28, 23F07, 23F30, 23G07, 23G11, 23G29, 23H01, 23I05, 23I06, 23I07, 23I23, 23I26, 23I28, 23I29, 23K18, 23K19.

Why it was recalled

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Root cause (FDA determination)

Component design/selection

Action the firm took

On May 17, 2024, URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Actions Required by B. Braun Medical Inc. (BBMI) Customer/User: 1. Review this notice in its entirety. Ensure that all users in your organization of the above-mentioned products, and other concerned personnel are informed about this voluntary correction. Post this notification where the affected products are stored. a. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The correction is to be extended to the consumer level. b. If you are a distributor that distributes partial cases, please ensure a copy of this notice is forwarded to your consignees. 2. Determine your current inventory. Review your inventory frequently to check these lot numbers. 3. Return the completed Urgent Medical Device Correction Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to recalls@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). For questions regarding the label and impacted Stimuplex A Needles, please call Customer Support at 1-800-227-2862. Adverse reactions or quality problems experienced with this product, or questions about this correction may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464. Adverse Reactions or quality problems in the United Sates may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Recalling firm

Firm

B Braun Medical Inc

Address

200 Boulder Dr, Breinigsville, Pennsylvania 18031-1532

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated

2024-05-17

Posted by FDA

2024-06-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #207882. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.